On 9 December 2016 New Regulations for Medical Devices were published. The operation of two regulatory activities, namely company licensing, and product registration were suspended, pending so-called “call-ups”. On 1 June 2017 amendments to the Medicines and Related Substances Act, 1965, came into effect, which also changes commercial aspects associated with medical devices.
1. Medical device companies (section 22C and regulation 27)
Medical device companies (i.e. manufacturers, importers and distributors) must have applied for a licence by 24 August 2017. If a license application acknowledgement letter is not produced, customs and port health will stop and confiscate products imported. Wholesalers will only have to apply for licensing early in 2018.
IMPLICATIONS FOR HEALTHCARE PROFESSIONALS: professionals who import their own medical devices, or who are part of companies importing medical devices, would have to apply for these licenses by 24 August 2017, or obtain exemption through an application under section 36(1) of the Medicines Act, which is directed to the MCC (now SAHPRA) and in the end has to be approved by the Minister of Health and published in the Government Gazette.
2. Medical devices (section 14 and regulation 28)
Medical devices itself will be subject to registration upon call-up from 2018. The definition of a medical device is as set out below, and include various capital equipment, consumables, and even assistive devices used in healthcare practices or as part of health care delivery:
“medical device” means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, including Group III and IV Hazardous Substances contemplated in the Hazardous Substances Act, 1973 (Act No. 15 of 1973)—
(a) intended by the manufacturer to be used, alone or in combination, for humans or animals, for one or more of the following:
(i) diagnosis, prevention, monitoring, treatment or alleviation of disease;
(ii) diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
(iii) investigation, replacement, modification or support of the anatomy or of a physiological process;
(iv) supporting or sustaining life;
(v) control of conception;
(vi) disinfection of medical devices; or
(vii) providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body; and
(b) which does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human or animal body, but which may be assisted in its intended function by such means.
IMPLICATIONS FOR HEALTHCARE PROFESSIONALS: professionals should, from 2018, keep tabs on products called up for registration, and the outcomes of registration processes. It is not known how long registration processes will take, but the Medicines Act requires regulations with timelines to be set, so as to avoid the current issues with delayed registration in pharmaceuticals.
3. Bonuses, rebates and incentives schemes (section 18A)
The Medicines Act now extends the well-known medicines prohibitions on bonus, rebates and incentives schemes (section 18A) to medical devices as well. It must be noted that medical devices are not subject to the Single Exit Price, meaning that differential pricing would be permitted, provided that such differential pricing is NOT a rebate, and does not otherwise contravene section 18A, competition law, the HPCSA rules or consumer legislation.
It is envisaged in section 18A(2) that regulations will govern the details of acceptable, and unacceptable practices under section 18A(1), but no such regulations have been proclaimed yet, so the general prohibition stand.
4. Samples, donations and appraisals (section 18B)
Section 18B prohibits sampling of devices (as it does sampling of medicines and have done so in the past). The definition of a sample, however, includes all “free supply” and therefore covers product donations, products used for research and testing purposes, etc. Regulations are envisaged, but have not yet been proclaimed, for “appraisal purposes” only.
As it is not possible to make regulations on donations, etc., there is no other option in law but to apply under section 36(2) for an exemption from this prohibition for any donations. This application is made to the Pricing Committee in the Department of Health, and must be granted by the Minister of Health and published in the Government Gazette.
5. Adverse events reporting (regulation 21)
All adverse events resulting from any medical device, must be reported to the MCC / SAHPRA. This is in spite of the absence of specific forms for devices (there are forms for medicines adverse event reporting). Reports should be made to the company, who should in turn make the report to the MCC/SAHPRA.
6. Business as usual?
The view has been expressed that, because medical devices are not yet registered, it is business as usual, and devices can be sampled, bonused, etc. This is not legally correct, as the same phrase, namely “medical device” is used throughout the Act and regulations, and no differentiation is made in, for example, regulation 21 stating “registered and unregistered” medical devices, and section 18A only referring to “registered” medical devices.
Furthermore, section 18A and 18B apply to both registered and unregistered medicines. As the wording is the same for all types of products, it is unlikely that a different interpretation could apply for medical devices, to what has been understood of medicines this far (and what was also confirmed to be applicable to unregistered complementary medicines).
The implementation of the medical device regulations, and in particular the company licensing, is not smooth sailing. Bringing amendments to the Medicines into effect on 1 June 2017 have further added confusion and uncertainty to the new system.
It is recommended that healthcare practitioners take a cautious approach, as violations of sections 22C, 18A and 18B constitute criminal offences under section 29 of the Medicines Act.
It is also recommended that exemption applications be made by societies and groups that may stand to be negatively effected by the incomplete regulatory regime.